A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV

HIV Clinical Trial

Official title:

Assessment of 13-valent Pneumococcal Conjugate Vaccine Effectiveness Among People With HIV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05794191
• Other study ID #: B1851217
• Status: Recruiting
• Start date: March 22, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to learn about how well a vaccine (Prevnar 13, PCV13) works in preventing disease in adults with HIV. The diseases studied are pneumonia. Mostly the ones caused by the bacteria - pneumococcus. This study also evaluates the type of pneumonia that is spread into the bloodstream. All participants in the study will be identified in health care databases. Adults with HIV will be identified by looking for a medical diagnosis that has confirmed HIV from the databases. Vaccination will be identified in the databases by looking for vaccine administration or for PCV13. Participants will be followed in the databases to see if they have one of the diseases mentioned above or not. The number of vaccinated participants with the diseases will be compared to the number participants without the vaccines but with the diseases. This will help to understand how well the vaccine worked.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. HIV infection defined as at least one inpatient or =2 outpatient codes related to HIV at least 30 days but no more than 730 days apart

2. At least 18 years of age at the time of the first HIV-related code

3. At least six months of continuous enrollment in medical and pharmacy plans after the first HIV-related code

Exclusion Criteria:

1. Evidence of PCV13 vaccination before the first HIV-related code

Related Conditions & MeSH terms

• HIV
• Infections, Pneumococcal
• Pneumococcal Infections
• Pneumonia

Intervention

Biological:
• Vaccine Administration
PCV13 administration

Locations

Country	Name	City	State
United States	Pfizer	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of invasive pneumococcal disease	Medical record for IPD diagnosed by ICD9 or ICD10 code	July,1 2014 - September 30, 2022 (duration of study)
Primary	Incidence of all cause pneumonia	Incidence of all cause pneumonia diagnosed by ICD9 - ICD10 code	July 1, 2014 - September 30, 2022 (duration of study)
Primary	Incidence of pneumococcal pneumonia	Diagnosis of pneumococcal pneumonia by ICD9 / ICD10 code	July 1, 2014 - September 30, 2022 (duration of study)
Secondary	Incidence of pneumococcal pneumonia or unspecified pneumonia		July 1, 2014 - September 30, 2022 (timeframe of study)
Secondary	Incidence of pneumonia of unspecified causes		July 1, 2014 - September 30, 2022 (timeframe of study)

External Links

•   To obtain contact information for a study center near you, click here.